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SummaryAim Data evaluating the complications of pulmonary vein isolation (PVI) using second-generation cryoballoons (CB) related to different anticoagulation regimes are limited. This study evaluates the total complications and the impact of novel oral anticoagulants (NOACs) compared to phenprocoumon on adverse events in the setting of PVI using CB. Methods and results PVI was performed using second-generation CB by two experienced investigators. A total of 409 patients (58.9% male; mean age = 61 ± 10 years) with atrial fibrillation were included in this study. In group I, 150/409 (36.7%) patients received phenprocoumon therapy, and in group II, 259/409 (63.3%) patients were treated with NOACs (rivaroxaban: n = 193; dabigatran: n = 48; and apixaban: n = 18). In both groups, the rates of major complications were similar (group I [phenprocoumon]: four pts (2.7%) vs. Group II [NOACs]: seven pts (2.7%); P = 0.999). In this cohort, 275 patients were ablated with the bonus freeze protocol, and 134 patients were ablated without bonus freezes. The procedure duration significantly decreased with the bonus freeze protocol from 102.3 ± 24.6 min to 68.5 ± 16.2 min (P < 0.001). The impact of the bonus freeze on the postprocedural increase of C-reactive protein (CRP) levels was significant compared to the postprocedural CRP levels after procedures without the bonus freeze protocol (postprocedural CRP level+ bonus protocol: 1.6 ± 1.2 mg/L vs. postprocedural CRP level+ nonbonus protocol: 1.3 ± 1.3 mg/L; P = 0.04). Conclusion The incidence of adverse events in PVI using the second-generation CB with the periprocedural administration of NAOCs was not significantly different compared to phenprocoumon. Further, large-scale randomized studies are needed to evaluate the safety of two anticoagulation regimes comparing vitamin K antagonists and NOACs, as well as different NOAC regimes, in patients undergoing PVI using cryoballoon ablation.

BACKGROUND Second-generation cryoballoon (CB-2) is associated with improved outcomes for pulmonary vein isolation (PVI) compared to first generation (CB-1). However, data regarding the predictors of pulmonary vein (PV) electrical reconnection are limited. In this study, we aimed to characterize the predilection sites and predictors of reconnection in patients with recurrent atrial tachyarrhythmia (ATa) after PVI using CB-1 and CB-2. METHODS A total of 59 patients (mean age: 62 ± 11 years and 66% male) with recurrent ATa after previous CB-PVI, using either a 28-mm CB-1 or CB-2, underwent repeat ablation. PV reisolation was performed by irrigated radiofrequency ablation using three-dimensional electroanatomical mapping systems. RESULTS Electrical PV reconnection was detected in 10 of 11 (91%) of CB-1 patients compared to 41 of 48 (85%) of CB-2 patients. Time to redo procedure after index CB-1 was 8.9 ± 10.2 months and 11.2 ± 7.0 months in CB-2. Bonus freeze was applied in all patients with CB-1 and 41% of the patients with CB-2. Superior quadrants of both superior PVs and inferior quadrants of the both inferior PVs exhibited higher predilection for conduction compared to other quadrants (P < 0.001). Multivariate binary logistic analysis revealed that right inferior PV (RIPV; odds ratio [OR]: 1.52, 95% confidence interval [CI]: 1.09-2.13, P = 0.014) and minimum temperature (OR: 1.09, 95% CI: 1.03-1.15, P = 0.004) were the independent predictors of electrical reconnection after CB-2 ablation. CONCLUSION Conduction gaps after CB-1 and CB-2 were higher in inferior PVs compared to superior PVs. The RIPV and minimum CB temperature were independent predictors of PV electrical reconnection after CB-2.